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Micro Medical Solutions Marks First U.S. Implants of MicroStent for Peripheral Artery Disease

A clinical trial is underway for the MicroStent microvascular device, which is designed to open occluded arteries and prevent below-the-knee amputations.

WILMINGTON, Massachusetts, June 7, 2018 — Micro Medical Solutions (MMS), an innovator in the field of microvascular interventions that aim to improve clinical outcomes and quality of life, announced a major milestone today in the development of its MicroStent technology, a vascular stent specifically designed to reduce below-the-knee amputations caused by critical limb ischemia (CLI) resulting from peripheral artery disease (PAD). After receiving approval from the U.S. Food and Drug Administration late last year to begin a clinical trial evaluating the device’s safety and efficacy, physicians have completed MicroStent’s first cases in the United States.

MicroStent received CE Mark approval in Europe in 2017 and continues to be studied internationally, as well as through this clinical trial of MicroStent in the United States. Co-principal investigator Dr. Robert E. Beasley performed the first procedure in the trial on April 25 at Mount Sinai Medical Center in Miami Beach, Florida. Dr. Beasley placed two 3.0 x 40mm stents in the anterior tibial artery (located between the knee and ankle) of a patient with CLI, fully restoring blood flow to a previously occluded vessel.

“We found implanting the MicroStent to be a very safe, quick, easy procedure. Using a retrograde pedal puncture, we used a small 3-French sheath to place two of these very low-profile, easy-to-deploy stents in the anterior tibial artery in about 30 minutes. Post-procedural ultrasound taken immediately, at 14 days and at 1 month showed a wide-open, unobstructed artery with excellent flow,” explained Dr. Beasley. “By returning sufficient blood flow to the lower leg, we were able to ensure adequate oxygenation to the tissue. As a result, a wound on the patient’s toe is now healing, and he is unlikely to require below-the-knee amputation. I’m hopeful that MicroStent will represent another tool to treat the devastating disease of CLI.”

Dr. Beasley has since performed four more MicroStent procedures. Dr. Craig Walker, co-principal investigator in the study with several cases completed, oversees the MicroStent research site at the Cardiovascular Institute of the South in Houma, Louisiana.

Dr. Walker noted, “With CLI, the ability to achieve patency in a vessel is paramount to saving both the vessel and the limb. Use of MicroStent, a self-expanding stent with great radial force and very little chronic outward force, has resulted in patent arteries with low probability of longterm stenosis. In fact, we have seen zero stenosis post-procedure on both ultrasound and angiography, and one patient remarked that dramatic pain relief occurred immediately after the MicroStent procedure. We anticipate that this critically important technology will continue to produce good outcomes and clinical results..”

Micro Medical Solutions CEO Gregory Sullivan added, “Everyone at MMS has been working together toward this achievement. We are very excited not only about this milestone, but also about the progress and momentum we are showing toward approval of MicroStent in the U.S. Ultimately, we hope MicroStent will fulfill its purpose to reduce preventable amputations and preserve patients’ freedom and quality of life.”

About Critical Limb Ischemia

Peripheral artery disease and critical limb ischemia (CLI) affect millions each year. It has been estimated that nearly 25% of CLI patients will undergo major amputation,1 and amputations due to CLI continue to escalate.2 For more information on CLI, visit www.micromedicalsolutions.net.

About Micro Medical Solutions

Micro Medical Solutions is on a mission to provide solutions to some of the most pressing unmet needs in microvascular intervention by helping to significantly reduce the rate of amputations, improve clinical outcomes and patient quality of life, and minimize the financial and human costs associated with the treatment of peripheral artery disease and critical limb ischemia. For more about Micro Medical Solutions, visit www.micromedicalsolutions.net.

About CLI

Peripheral artery disease (PAD) and critical limb ischemia (CLI) affected 215 million people worldwide in 2015, predicted to be 230 million by 2020.1 CLI currently afflicts 2.8 to 3.5 million of those with PAD and is projected to rise to 4.5 to 5.6 million.2 Rates of amputations in the general population with PAD are declining, but amputations in CLI continue to escalate. It has been estimated that 25% of CLI patients will undergo major amputation. Prognosis with respect to limb preservation in CLI patients is poor, particularly in no-option CLI patients, where six-month major amputation rates have been reported to be as high as 50%.3 If something doesn’t change, the number of amputations due to CLI could exceed one million by 2030.